Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

End-Stage Kidney Disease Clinical Trial

— RESOLVE  

Official title:

Randomised Evaluation of Sodium Dialysate Levels on Vascular Events

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02823821
• Other study ID #: GI-AU-RM-2016-01
• Status: Recruiting
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: University of Sydney
• Contact: Grace Balicki
• Email: grace.balicki[@]sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol/l and 137mmol/l, on major cardiovascular events and death in patients receiving maintenance haemodialysis.

Description:

RESOLVE is a pragmatic, cluster-randomised, open-label study designed to evaluate in real-world conditions the comparative effectiveness of two default dialysate sodium concentrations.

Dialysis sites will be randomised in a 1:1 ratio to a default dialysate sodium concentration of 137mmol/l or 140mmol/l. 'Default' is defined as the use of the allocated dialysate sodium for ≥ 90% of delivered dialysis sessions in the unit. All other care will be according to standard local practices as determined by the site.

Outcomes will be assessed on individual patients dialysing at those sites. Sites will be asked to consent to participation while waiver or opt-out consent will be sought for individual patients.

It is anticipated that site accrual will occur over 5-7 years with average study duration expected to be approximately 2-5 years. The actual length of the study will be end-point determined.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The site inclusion criteria are:

• Predominantly dialyses adults (=18 years old) receiving maintenance haemodialysis

• Rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15%

• Has a minimum of 10 dialysis recipients at time of randomisation

• Utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration)

• Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. Brief trips by patients to a parent or other unit do not exclude a site)

• Willing to accept randomisation to either intervention (as determined by nominated Director of Unit)

• Is not a home dialysis training or support unit. [Sites that include both in-center/satellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter/satellite component of the site].

The exclusion criteria are:

• Not able to comply with data collection methods

Related Conditions & MeSH terms

• End-Stage Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• Default dialysate sodium concentration of 137mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
• Default dialysate sodium concentration of 140mmol/l
Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Auburn Hospital	Auburn
Australia	Flinders Medical Centre	Bedford Park
Australia	Moorabbin Hospital	Bentleigh East
Australia	Sunshine Coast University Private Hospital	Birtinya
Australia	Princess Alexandra Hospital	Brisbane
Australia	Redlands Hospital	Brisbane
Australia	Bundaberg Hospital	Bundaberg
Australia	Caloundra Hospital	Caloundra
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	The Canberra Hospital	Canberra
Australia	Peninsula Health	Frankston
Australia	Gympie Hospital	Gympie
Australia	Ipswich Hospital	Ipswich
Australia	Mackay Base Hospital	Mackay
Australia	Logan Hospital	Meadowbrook
Australia	Casey Hospital	Melbourne
Australia	Cranbourne Integrated Care Centre	Melbourne
Australia	Monash Health Community Dandenong	Melbourne
Australia	Nambour General Hospital	Nambour
Australia	Hampstead Dialysis Centre	Northfield
Australia	Hervey Bay Hospital	Pialba
Australia	Royal North Shore Hospital	St Leonards
Australia	Sunshine Coast University Hospital	Sunshine Coast
Australia	Blacktown Regional Dialysis Centre	Sydney
Australia	Concord Repatriation and General Hospital	Sydney
Australia	Mt Druitt Community Dialysis Centre	Sydney
Australia	Nepean Hospital	Sydney
Australia	Sydney Adventist Hospital	Sydney
Australia	Westmead Hospital	Sydney
Australia	The Queen Elizabeth Hospital	Woodville South
Canada	Brantford General Hospital	Brantford	Ontario
Canada	Chatam-Kent Health Alliance	Chatham	Ontario
Canada	St Joseph's Healthcare	Hamilton	Ontario
Canada	Stoney Creek	Hamilton
Canada	Hanover District Hospital	Hanover	Ontario
Canada	Belleville	Kingston
Canada	Brockville	Kingston
Canada	Kingston General	Kingston
Canada	Napanee	Kingston
Canada	Perth and Smith Falls	Kingston
Canada	Picton	Kingston
Canada	Adam Linton Dialysis Unit - Victoria Hospital	London	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Westmount Kidney Care Centre	London	Ontario
Canada	Grey Bruce Health Services	Owen Sound	Ontario
Canada	Bluewater Hospital	Sarnia	Ontario
Canada	Huron Perth Hospital Partnership	Stratford	Ontario
Canada	Tillsonburg District Memorial Hospital	Tillsonburg	Ontario
Canada	St. Michael's Hospital	Toronto
Canada	Woodstock General Hospital	Woodstock	Ontario
Germany	Nephrologisches Zentrum Albstadt	Albstadt
Germany	Praxis für Nierenkrankheiten Berlin Hellersdorf	Berlin
Germany	Dialyse am Kortumpark Bochum	Bochum
Germany	Dialysezentrum Darmstadt	Darmstadt
Germany	Dialysezentrum Elsenfeld	Elsenfeld
Germany	Nephrologisches Zentrum Hechingen	Hechingen
Germany	Arbeitsgemeinschaft Heimdialyse Saar e.V.	Homburg
Germany	Dialysezentrum Langen	Langen
Germany	KfH Nierenzentrum Lichtenfels	Lichtenfels
Germany	Universitätsmedizin Mainz, Dialysestation 605-5E	Mainz
Germany	KfH Nierenzentrum München Schwabing	Munich
Germany	UBAG Öhringen	Öhringen
Germany	Dialysezentrum Schweinfurt	Schweinfurt
Germany	Dialysezentrum Siegburg	Siegburg
Germany	Nephrologie - Dialyse - Christliches Klinikum Unna	Unna
Germany	Nephrologisches Zentrum Villingen-Schwenningen -Tuttlingen	Villingen-Schwenningen
India	ESI Hospital	Adityapur	Jharkand
India	Leelawati Hospital	Ambala	Haryana
India	Jyothi Hospital	Balasore	Odisha
India	Koshys Hospital, Ramamurthy Nagar	Bengaluru	Karnataka
India	Nephroplus Basaveshwaranagar	Bengaluru	Karnataka
India	Kar Clinic & Hospital Pvt. Ltd.	Bhubaneswar	Odisha
India	Neelachal Hospital, Kharvel Nagar	Bhubaneswar	Odisha
India	K.M Memorial Hospital and Research Centre	Bokaro	Jharkhand
India	Bharat Baug	Borivali West	Mumbai
India	Nephroplus Borivali Standalone	Borivali West	Mumbai
India	Deepam Hospitals, Pallavaram	Chennai	Tamilnadu
India	Area Hospital, Kothapeta Road,Chirala, Andhra Pradesh	Chirala	Andhra Pradesh
India	KG Hospital	Coimbatore	Tamil Nadu
India	Asarfi Hospital	Dhanbad	Jharkhand
India	Medical Superintendent Government Hospital	Gudur	Andhra Pradesh
India	Government General Hospital	Guntur	Andhra Pradesh
India	Medical Superintendent District Hospital	Hindupur PPP	Andhra Pradesh
India	Fortis Suchirayu Hospital	Hubli	Karnataka
India	Citizens Specialty Hospital	Hyderabad	Telangana
India	ESI Multi-Specialty Hospital	Hyderabad	Telangana
India	Vintage Plaza Nephroplus, Road no. 10, Banjara Hills	Hyderabad	Telangana
India	Vishesh Hospital Pvt. Ltd, Geeta Bhawan Chouraha	Indore	Madhya Pradesh
India	Government Hospital	Kakinada	Andhra Pradesh
India	Government Area Hospital, Kanigiri, Andhra Pradesh	Kanigiri	Andhra Pradesh
India	Madhuraj Hospital	Kanpur	Uttar Pradesh
India	Government Hospital	Khammam	Telangana
India	Aysha Hospital	Kilpauk	Chennai
India	Retteri Sri Kumaran Health Centre	Kolathur	Chennai
India	Health Point Hospital, Prannth Pandit Street	Kolkata	West Bengal
India	Main Hospital, SCCL	Kothagudem	Khammam
India	Government General Hospital	Kurnool	Andhra Pradesh
India	Ajanta Hospital	Lucknow	Uttar Pradesh
India	Satguru Partap Singh Apollo Hospitals	Ludhiana	Punjab
India	Government Hospital, Machilipatnam PPP, Andhra Pradesh	Machilipatnam	Andhra Pradesh
India	Government Area Hospital	Markapur	Andhra Pradesh
India	Hitwardhak Mandal Hospital	Mumbai	Maharashtra
India	Suraksha Multispecialty Hospital	Nalgonda	Telangana
India	Government Hospital	Nandyal	Andhra Pradesh
India	Area Hospital	Narsipatnam	Andhra Pradesh
India	Neyveli Lignite Corporation Hospital	Neyveli	Tamilnadu
India	Sudha Hospital, Vadalur	Neyveli	Tamil Nadu
India	Surbhi Hospital Pvt. Ltd, Sector 35	Noida	Uttar Pradish
India	Greater Kailash Hospital	Old Palasia	Indore
India	Government Area Hospital	Palakonda, Srikakulam District	Andhra Pradesh
India	CHC Government Hospital	Palasa	Andhra Pradesh
India	Government Area Hospital	Parvathipuram	Andhra Pradesh
India	Ford Hospital, Khemnichak, Patna	Patna	Bihar
India	Janak Dulari Hospital, Hanuman Nagar	Patna	Bihar
India	Government Hospital	Proddatur	Andhra Pradesh
India	Lokmanya Hospital	Pune	Maharashtra
India	Government Hospital	Rajahmundry	Andhra Pradesh
India	Bhagwan Mahavir Medical Superspeciality Hospital	Ranchi	Jharkhand
India	Guru Nanak Hospital and Research Centre	Ranchi	Jharkhand
India	Nephroplus Standalone Dialysis Center, Easy Marredpally	Secunderabad	Telangana
India	CHC Hospital, Sompeta, Andhra Pradesh	Sompeta	Andhra Pradesh
India	Rajiv Gandhi Institute of Medical Sciences, Srikakulam PPP, Andhra	Srikakulam	Andhra
India	Greater Kailash Hospital	Tadepalligudem	Andhra Pradesh
India	Minimal Access Surgery Clinic Pvt Ltd	Tamluk	West Bengal
India	Chirayu Hospital	Thane	Maharashtra
India	Manasa Kidney Foundation	Tirupati	Andhra Pradesh
India	Baroma Sirona Hospital	Uttar Mechgram	West Bengal
India	Government General Hospital, Vijayavada PPP, Andhra Pradesh	Vijayavada	Andhra Pradesh
India	King George Government Hospital	Visakhapatnam	Andhra Pradesh
Malaysia	Hospital Ampang	Ampang
Malaysia	Hospital Sultanah Nora Ismail	Batu Pahat
Malaysia	Hospital Beaufort	Beaufort
Malaysia	Hospital Pulau Pinang	George Town
Malaysia	Pusat Dialisis NKF- Yayasan Dialisis Pendidikan Akhlak Perak	Ipoh
Malaysia	Hospital Sultan Ismail	Johor Bahru
Malaysia	Hospital Sultanah Aminah	Johor Bahru
Malaysia	Hospital Kajang	Kajang
Malaysia	Hospital Serdang	Kajang
Malaysia	Hospital Tuanku Fauziah	Kangar
Malaysia	Pusat Rawatan Dialisis Tuanku Syed Putra - NKF	Kangar
Malaysia	Hospital Tengku Ampuan Rahimah	Klang
Malaysia	Pusat Daillisis NKF - Kelab Apex	Klang
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu
Malaysia	Hospital Likas	Kota Kinabalu
Malaysia	Hospital Queen Elizabeth II	Kota Kinabalu
Malaysia	Hospital Kuala Kangsar	Kuala Kangsar
Malaysia	Hospital Kuala Lipis	Kuala Lipis
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	Pusat Dialisis NKF-Fungates Superflow	Kuala Lumpur
Malaysia	Pusat Dialisis NKF-Nanyang	Kuala Lumpur
Malaysia	Universiti Kebangsaan Malaysia Medical Centre	Kuala Lumpur
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Malaysia	Hospital Tengku Ampuan Afzan	Kuantan
Malaysia	Hospital Kudat	Kudat
Malaysia	Hospital Kulim	Kulim
Malaysia	Hospital Labuan	Labuan
Malaysia	Hospital Sultanah Bahiyah	Langgar
Malaysia	Haemodialysis Unit Klinik Kesihatan Lenggong	Lenggong
Malaysia	Pusat Hemodialisis Komuniti Cheng	Malaka
Malaysia	Hospital Pakar Sultanah Fatimah	Muar
Malaysia	Hospital Seberang Jaya	Permatang Pauh
Malaysia	Pusat Dialisis NKF - Chempaka	Petaling Jaya
Malaysia	Hospital Shah Alam	Shah Alam
Malaysia	Universiti Teknologi Mara	Shah Alam
Malaysia	Hospital Sultan Abdul Halim	Sungai Petani
Malaysia	Hospital Sungai Siput	Sungai Siput
Malaysia	Hospital Tambunan	Tambunan
Malaysia	Hospital Sultan Haji Ahmad Shah	Temerluh
United Kingdom	Altrincham General Hospital Dialysis Unit	Altrincham
United Kingdom	Tameside Renal Dialysis Unit	Ashton-under-Lyne
United Kingdom	Barnet Satellite Unit	Barnet
United Kingdom	Barnsley Dialysis Unit	Barnsley
United Kingdom	Bath Dialysis Unit	Bath
United Kingdom	Bedford Renal Unit	Bedford
United Kingdom	Bexhill Dialysis Unit	Bexhill-on-Sea
United Kingdom	Hexagon Towers Dialysis Unit	Blackley
United Kingdom	Bolton Kidney Care Centre	Bolton
United Kingdom	St Luke's Hospital Renal Ward	Bradford
United Kingdom	Bridgwater Dialysis Unit	Bridgwater
United Kingdom	Brighton Sussex Kidney Unit	Brighton
United Kingdom	Cossham Dialysis Unit	Bristol
United Kingdom	South Bristol Dialysis Unit	Bristol
United Kingdom	Bromley Dialysis Unit	Bromley
United Kingdom	Broomfield Hospital	Broomfield
United Kingdom	Cannock Haemodialysis Unit	Cannock
United Kingdom	Chesterfield Dialysis Unit	Chesterfield
United Kingdom	Clacton (Diaverum)	Clacton-on-Sea
United Kingdom	Colchester (Diaverum)	Colchester
United Kingdom	Clay Lane	Coventry
United Kingdom	University Hospitals Coventry & Warwickshire Main Unit	Coventry
United Kingdom	Crawley Dialysis Unit	Crawley
United Kingdom	Leighton	Crewe
United Kingdom	Cromer Hospital Dialysis Unit	Cromer
United Kingdom	Darlington Dialysis Unit	Darlington
United Kingdom	Dartford Dialysis Unit	Dartford
United Kingdom	Dover Renal Unit	Dover
United Kingdom	Edgware Satellite Unit	Edgware
United Kingdom	Epsom Dialysis Unit	Epsom
United Kingdom	Heavitree	Exeter
United Kingdom	Farnborough Dialysis Unit	Farnborough
United Kingdom	Cotswold Dialysis Centre	Gloucester
United Kingdom	Severn	Gloucester
United Kingdom	James Paget Renal Unit	Great Yarmouth
United Kingdom	Grimsby Renal Unit	Grimsby
United Kingdom	Harlow Renal Unit	Harlow
United Kingdom	Hayes Hospital	Hayes
United Kingdom	Honiton	Honiton
United Kingdom	Chiltern Renal Unit	Houghton Regis
United Kingdom	Fresenius Hull Dialysis Unit	Hull
United Kingdom	West Middlesex	Isleworth
United Kingdom	Kingston Satellite Dialysis Unit	Kingston
United Kingdom	Collierswood Dialysis Unit	London
United Kingdom	King George Hospital	London
United Kingdom	Mary Rankin Satellite Unit	London
United Kingdom	North Wandsworth Dialysis Unit	London
United Kingdom	Royal London Hospital	London
United Kingdom	Whipps Cross Hospital	London
United Kingdom	Ludlow Dialysis Unit	Ludlow
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Manchester Royal Infirmary Renal Dialysis Unit	Manchester
United Kingdom	Octagon Renal Satellite	Manchester
United Kingdom	Margate Renal Unit	Margate
United Kingdom	James Cook	Middlesbrough
United Kingdom	North Ormesby	Middlesbrough
United Kingdom	Harrogate	North Yorkshire
United Kingdom	Friarage Hospital	Northallerton
United Kingdom	Lucy Deane (George Eliot)	Nuneaton
United Kingdom	Oldham Dialysis Unit	Oldham
United Kingdom	Newham Hospital	Plaistow
United Kingdom	Eastbourne (Polegate) Dialysis Unit	Polegate
United Kingdom	Rochdale Dialysis Unit	Rochdale
United Kingdom	Queen's Hospital	Romford
United Kingdom	Rotherham Dialysis Unit	Rotherham
United Kingdom	St Cross (Ash Unit)	Rugby
United Kingdom	Salford Renal Unit	Salford
United Kingdom	Scarborough	Scarborough
United Kingdom	Scunthorpe Dialysis Centre	Scunthorpe
United Kingdom	Peter Moorhead Unit	Sheffield
United Kingdom	Renal G Floor	Sheffield
United Kingdom	Sheffield Dialysis Unit	Sheffield
United Kingdom	Shrewsbury Renal Unit	Shrewsbury
United Kingdom	Smethwick Dialysis Centre	Smethwick
United Kingdom	St Albans Dialysis Unit	St Albans
United Kingdom	County Hospital	Stafford
United Kingdom	Lister Renal Unit	Stevenage
United Kingdom	Stockport NHS Dialysis Unit	Stockport
United Kingdom	North Tees	Stockton-on-Tees
United Kingdom	Royal Stoke	Stoke-on-Trent
United Kingdom	Stratford Dialysis Centre	Stratford-upon-Avon
United Kingdom	St. Helier Dialysis Unit	Sutton
United Kingdom	Sutton Dialysis Unit	Sutton
United Kingdom	Taunton Dialysis Centre	Taunton
United Kingdom	Hollinswood House Renal Unit	Telford
United Kingdom	Croydon Dialysis Unit	Thornton Heath
United Kingdom	South Devon Satellite Kidney Unit	Torquay
United Kingdom	Tottenham Hale Satellite Unit	Tottenham
United Kingdom	Wigan Renal Unit	Wigan
United Kingdom	Ashford Renal Unit	Willesborough
United Kingdom	Pond Lane Dialysis Unit	Wolverhampton
United Kingdom	Woolwich Dialysis Unit	Woolwich
United Kingdom	Worthing Dialysis Unit	Worthing
United Kingdom	Easingwold	York
United Kingdom	York Hospital	York

Sponsors (12)

Lead Sponsor

Collaborator

University of Sydney

Australasian Kidney Trials Network, Australia & New Zealand Dialysis & Transplant Registry, Comprehensive Clinical Trials Unit, University College London, Institute for Clinical Evaluative Sciences, Malaysian Renal Registry, Malaysian Society of Nephrology, Peking University People's Hospital, St. Michaels Hospital, The George Institute for Global Health, China, The George Institute for Global Health, India, University Hospital Wuerzburg, Medizinische Klinik EINS

Countries where clinical trial is conducted

Australia,  Canada,  Germany,  India,  Malaysia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of an event in the primary composite outcome	Primary outcome is a composite of major cardiovascular events (hospitalised acute myocardial infarction, hospitalised stroke) and all-cause death. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.	Through to study completion (estimated to occur after an average of 5 years follow up)
Secondary	Time to first occurrence of an event in the secondary composite outcome	Secondary outcome comprises major cardiovascular events (hospitalized acute myocardial infarction, hospitalized stroke), all-cause death and hospitalized heart failure. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.	Through to study completion (estimated to occur after an average of 5 years follow up)
Secondary	Time to first occurrence of each of the individual components of the composite outcomes.	These components are hospitalised myocardial infarctions, hospitalised strokes, hospitalised heart failures and all-cause deaths. Study completion is endpoint driven, but is expected to be when the average follow up is around 5 years.	Through to study completion (estimated to occur after an average of 5 years follow up)